Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as fully anonymized data sets, derived from original clinical records on appropriately informed subjects.
This is a patient-outcomes Registry for subjects of any age who are provided in routine clinical practice with one or more MED-EL hearing devices. The Registry aims to collect data for hypothesis generation on subject device use, auditory performance, quality of life and health-related utilities, across different types of implantable and non-implantable hearing devices from MED-EL company. Subjects will be evaluated with a set of standardized tests and questionnaires prior to implantation or prior to initial device activation (baseline) and at follow-up intervals according to the clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable or non-implantable MED-EL hearing solution | Device | Receipt of an implantable or non-implantable MED-EL hearing solution |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Demographics | 5 years | |
| Hearing Threshold level | Audiometry testing (unaided) | 5 years |
| Speech test | Results from speech tests | 5 years |
| HISQUI (Hearing Implant Sound Quality Index) | Results from the HISQUI questionnaire | 5 years |
| APHAB (Abbreviated Profile of Hearing Aid Benefit) | Results from the APHAB questionnaire | 5 years |
| ASC (Auditory Skills Checklist) | Results from the ASC questionnaire | 5 years |
| APSQ (Audio Processor Satisfaction Questionnaire) | Results from the APSQ questionnaire | 5 years |
| LEAQ (LittlEars Auditory Questionnaire) | Results from the LEAQ questionnaire | 5 years |
| HL-QOL | Results from the HL-QOL questionnaire | 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
No study population defined
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmine Rinnofner | Contact | +43 57 788 1694 | jasmine.rinnofner@medel.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Polterauer-Neuling, Dr. | Klinikum der Universität München Campus Großhadern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholisches Klinikum Bochum | Recruiting | Bochum | 44787 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde | Recruiting | Dresden | 01307 | Germany |
|
| Universitätsklinikum der Goethe-Universität | Recruiting | Frankfurt | 60590 | Germany |
|
| Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
|
| Klinikum der Universität München Campus Großhadern | Recruiting | München | 81377 | Germany |
|
| Evangelisches Krankenhaus Oldenburg | Recruiting | Oldenburg | 26122 | Germany |
|
| Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner" | Recruiting | Rostock | 18057 | Germany |
|
| Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen | Recruiting | Tübingen | 72076 | Germany |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |